Category: Surgical Therapy: Parkinson's Disease
Objective: In this study we report the first three cases of a new, CE-marked system for deep brain stimulation.
Background: The PMCF study is a a Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation System (NCT04329676).
Method: Participants with idiopathic Parkinson’s Disease and eligible for bilateral DBS were included. The 12-contact directSTIM DBS system was implanted at least 2 months prior to evaluation. Omnidirectional stimulation was achieved by activating all 3 electrode contacts at one level (360°) and directional stimulation was achieved via 1 electrode contact (120°). Once the single best treatment level was identified, the therapeutic window was determined at the best level by determining the lowest current that maximally released motor symptoms and the lowest current that elicited sustained side effects under blinded conditions.
Results: In the first three patients of the trial, the therapeutic window obtained with stimulation in the best single direction was 1.5 mA (range 0.4-3.0) greater than with omnidirectional stimulation at the same level (n = 3 patients). No serious treatment-emergent adverse events were reported.
Conclusion: Our preliminary findings indicate that the therapeutic window is larger with directional stimulation than with omnidirectional stimulation, consistent with previous findings using different systems.
To cite this abstract in AMA style:W. Polanski, S. Sobottka, V. Coenen, A. Frank, B. Falkenburger. Initial Postmarketing Real World Experience with directSTIM™ DBS System: A Case Series [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/initial-postmarketing-real-world-experience-with-directstim-dbs-system-a-case-series/. Accessed September 27, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/initial-postmarketing-real-world-experience-with-directstim-dbs-system-a-case-series/